Safety and Efficacy Study of an Interactive Wound Dressing (KC002) for the Treatment of Diabetic Foot Ulcers (KC-002PT)
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|ClinicalTrials.gov Identifier: NCT00330265|
Recruitment Status : Unknown
Verified August 2008 by KeraCure.
Recruitment status was: Recruiting
First Posted : May 26, 2006
Last Update Posted : August 26, 2008
The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study.
Participation in the study is for 24 weeks.
|Condition or disease||Intervention/treatment||Phase|
|Foot Ulcer Diabetes||Device: KC-002 Other: Conventional Wound Therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Controlled, Unmasked, Multiple Treatment, Multi-Center Clinical Trial to Evaluate the Efficacy and Safety of an Interactive Wound Dressing Containing Cultured Keratinocytes Versus Conventional Wound Therapy for the Treatment of Diabetic Foot Ulcers|
|Study Start Date :||January 2006|
|Estimated Primary Completion Date :||March 2009|
|Estimated Study Completion Date :||September 2009|
Determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus.
Conventional Wound Therapy
Other: Conventional Wound Therapy
Normal Saline Dressings
- Percent of subjects achieving complete or (100%) study wound closure by week 12 after initial treatment [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330265
|Contact: M Meekfirstname.lastname@example.org|